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  1. U.S. FDA warns Juul over its marketing practices

    Reuters via Yahoo FinanceSep 09 15:46 PM

    The FDA said it was concerned that Juul's representation of products may look like switching to its vaping device was a safer alternative to cigarettes.

  2. SILVER SPRING, Md., Sept. 3, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive ...

  3. Why This Analyst Set A $3 Price Target On SINTX Shares

    Benzinga via Yahoo FinanceSep 12 13:46 PM

    The FDA-registered silicon nitride medical device manufacturing facility company SINTX Technologies Inc (NASDAQ: SINT) boasts five near-term catalysts that should help the stock double ...

  4. Glaxo's Asthma Drug Nucala Gets FDA Nod for Pediatric Use

    Zacks via Yahoo FinanceSep 13 14:08 PM

    GlaxoSmithKline plc GSK announced that the FDA has granted approval to Nucala as an add-on treatment for severe eosinophilic asthma in the pediatric patient population, aged six to 11 ...

  5. While the FDA is expected to give its decision in mid-2020, the same from EMA is expected in the second half of 2020. The BLA and MAA filings were based on two phase III studies — SEQUOIA ...

  6. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.

  7. Ardelyx Gets FDA Approval for Ibsrela As IBS-C Treatment

    Zacks via Yahoo FinanceSep 13 15:08 PM

    Data from the studies demonstrated that Ibsrela achieved a statistically significant reduction in constipation and abdominal pain. Ardelyx is in discussions to ink a collaboration deal to support ...

  8. ZBH recently received the FDA 510(k) consent for its flagship Persona Revision Knee System for revision knee replacement procedures. With this launch, the company expects to broaden its ...

  9. SILVER SPRING, Md., Sept. 11, 2019 /PRNewswire/ -- Today, the Trump Administration announced that as part of its ongoing work to tackle the epidemic of youth e-cigarette use, the FDA ...

  10. Government plans to ban flavors used in e-cigarettes

    Associated Press via Yahoo FinanceSep 11 22:35 PM

    The Food and Drug Administration will develop guidelines to remove from the market all e-cigarette flavors except tobacco, Health and Human Services Secretary Alex Azar told reporters during ...

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